MAUDE Adverse Event Report: AVAILMED 2000 ML TPN BAG; SET, I.V. FLUID TRANSFER

Catalog Number H938740

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 06/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device was received and evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an exactamix eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag was leaking from the center valve.The leak was observed prior to use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

It was reported that two (2) exactamix eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags leaked.One (1) actual device was received for evaluation.Visual inspection was performed and dried solution was observed at the spike port cap surface.Functional testing using tap water was performed and a leak from the spike port cap was identified.The reported condition was verified.The cause of the condition was determined to be a manufacturing issue.This issue is being further investigated.The second device was not received for evaluation; therefore, a device analysis could not be completed.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: 2000 ML TPN BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): AVAILMED; tijuana, baja california
• Manufacturer (Section G): AVAILMED; c. industrial lt 001 mz 105; no 20905 int a, col cd ind.; tijuana, baja california 22444 ; MX 22444
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7687767
• MDR Text Key: 114055905
• Report Number: 1416980-2018-04334
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477244
• UDI-Public: (01)00085412477244
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K900585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: H938740
• Device Lot Number: 60049819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1